8 
drugs. To the extent that either recombinant DNA or micro- 
oganisms are used as "precursors, intermediates, and catalysts 
intended for use in the production of drugs" or "for drug 
research and development," under the terms of TSCA, these 
materials are to be regulated by the Food and Drug Adminis- 
tration. 7/ 
EPA also seeks excessive authority through its expansive 
interpretation of the term "new chemical substance.” EPA has 
asserted premarketing notification authority, available only for 
new chemical substances, over pre-existing polypeptides; thus, 
apparently, it would characterize as "new" even traditional, 
existing products, whenever those products have been produced 
through the genetic engineering process. This assertion of 
authority, however, is suspect since TSCA defines "new chemical 
substance" as "any chemical substance which is not included in 
the chemical substance list compiled and published under [the 
provision for reporting and retention of information]." 8/ 
Presumably, many products of Genentech and similar companies 
7/ See H.R. No. 94-1341 at 11; 15 U.S.C. § 2602 ( 1 ) (B ) (vi ) . 
8/ See 15 U.S.C. § 2602(9). The reporting provision is 15 
U.S.C. § 2607(b). EPA might argue that this characteriza- 
tion is no different than FDA’s characterization of all 
genetically engineered pharmaceuticals as "new drugs." 
There, however, "new" is defined by lack of established 
safety and efficacy and not by absence from a specified 
inventory. See 21 U.S.C. § 321(p). 
[ 708 ] 
